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Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors

Primary Purpose

Cancer Survivor, Estrogen Receptor-positive Breast Cancer, Stage IA Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise intervention
laboratory biomarker analysis
questionnaire administration
quality-of-life assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Survivor

Eligibility Criteria

56 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • The study will be conducted in women who have been diagnosed with a first primary invasive estrogen receptor (ER) positive (+) breast cancer (stages I-IIIa) who are within the first 3 years post-treatment
  • The study will be conducted in postmenopausal women
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately

  • Postmenopausal, defined as meeting any of the following criteria:

    • Periods stopped more than 6 months ago
    • Bilateral oophorectomy
    • Not already classified as pre- or peri-menopausal
    • Started using hormone therapy for menopausal symptoms before periods stopped, and/or
    • Hysterectomy before age 56 years but aged 56 years or more at baseline
  • Any body mass index (BMI)
  • Sedentary (have not participated in a regular exercise program in the past 12 months)
  • Nonsmokers (not smoking during previous 12 months)
  • Willing and able to travel to the exercise facility
  • Diagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa)
  • Have undergone a lumpectomy or mastectomy
  • Have completed adjuvant chemotherapy and/or radiation within the past 3 years prior to study enrollment (when cytokine levels are predicted to be high) and able to initiate an exercise program
  • May use adjuvant endocrine therapy if use will be continued for duration of study period
  • All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
  • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
  • Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked to stop use during study period)
  • Currently taking postmenopausal hormone replacement therapy
  • Stage IV or distant metastatic disease
  • Planned reconstructive surgery with flap repair during study period
  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm I (exercise intervention)

Arm II (no formal exercise intervention)

Arm Description

Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at Curves will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine.

Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.

Outcomes

Primary Outcome Measures

Change in 60 minutes mean olive tail moments measured by the Comet assay
Comet assay data will be analyzed according to methods by Wiklund et al. Log-transformed, mean Olive tail moments, assessing DNA damage, will be calculated and compared using a paired t-test. For the ex vivo analyses using a challenge assay, Log-transformed, mean Olive tail moments will be calculated before and after the introduction of the damaging agent at 0, 1 and 6 hours. Differences between the changes will be analyzed using the paired t-test. Multivariate analysis of variance (MANOVA) for repeated measure will be performed and linear regression models will be fitted.
Change in level of interleukin-6 (IL-6) cytokine measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Paired t-tests will be used to compare pre-exercise cytokine concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.
Change in telomerase activity using the Trypan blue method and ImagedQuant
Paired t-tests will be used to compare pre-exercise telomerase activity in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.

Secondary Outcome Measures

Change in the number of gamma-H2A histone, member X (H2AX) foci measured by the gamma-H2AX assay
First, gamma-H2AX foci will be counted, and compared using the paired t-test. Second, for the ex vivo analyses gamma-H2AX foci will be counted before and after the introduction of a damaging agent at 0, 1 and 6 hours. For each time point, a foci change will be obtained. Differences in the foci changes at baseline and 16-weeks will be analyzed using the paired t-test. MANOVA for repeated measures will be performed to allow for the assessment of overall multivariate and univariate results, and linear regression models will be fitted.
Change in C-reactive protein (CRP) and levels of cytokines measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Paired t-tests will be used to compare pre-exercise CRP and cytokines concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.
Adherence to the study protocol
The CurvesSmart card will record both adherence of going to the sessions and completion of the circuit. Adherence will be analyzed as a continuous variable. During the 16-week testing session, women will be asked what barriers to adherence they may have experienced during the intervention.
Changes in weight
A repeated measures analysis of variance (ANOVA) will be used.
Changes in BMI
A repeated measures ANOVA will be used.
Changes in percent body fat
A repeated measures ANOVA will be used.
Changes in cardiopulmonary function
A repeated measures ANOVA will be used.
Changes in muscle strength
A repeated measures ANOVA will be used.
Changes in functional capacity
A repeated measures ANOVA will be used.
Changes in quality of life scores
Changes in quality of life scores will be measured by Cohen's 10-item perceived stress scale, the Fatigue Symptom Inventory, Rosenberg Self-esteem Scale, the Centers for Epidemiology Depression (CESD) Scale, the state trait anxiety index (STAI), the Functional Assessment of Cancer Therapy-Breast scale (FACT-B+4), and Short Form-36 (SF-36) questionnaires. A repeated measures ANOVA will be used.
Incidence of exercise-attributed injury
During the 16-week testing session, women will be asked details about any injuries or discomfort they may have experienced during the participation in the exercise intervention.
Change in telomere length as measured by quantitative polymerase chain reaction
Paired t-tests will be used to compare pre-exercise telomere length in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.

Full Information

First Posted
September 5, 2014
Last Updated
March 17, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02235051
Brief Title
Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors
Official Title
Deciphering the Breast Cancer Exercise Paradox: The Role of DNA Repair and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2014 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized pilot trial studies how well an exercise intervention works in preventing breast cancer from coming back in postmenopausal breast cancer survivors. Regular exercise may be able to train the body to repair deoxyribonucleic acid (DNA) more efficiently and to respond to inflammation more proficiently, helping to prevent primary and recurrent breast cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To test the hypothesis that regular exercise increases DNA repair capacity. II. To test the hypothesis that regular exercise reduces inflammatory response. III. To test the hypothesis that regular exercise modulates telomerase activity. SECONDARY OBJECTIVES: I. To assess adherence to the study protocol. II. To examine differences in body composition before and after the exercise intervention. III. To examine differences in fitness before and after the exercise intervention. IV. To test the hypothesis that regular exercise increases quality of life in breast cancer survivors. V. To examine the safety of the exercise intervention. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at a Curves facility will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine. ARM II: Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Estrogen Receptor-positive Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Postmenopausal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (exercise intervention)
Arm Type
Experimental
Arm Description
Patients participate in a supervised Curves exercise program three days a week for 16 weeks. The circuit-style workout consists of 14 exercises constructed with pneumatic or hydraulic resistance that target opposing muscle groups in a concentric-only fashion. Each session at Curves will include two complete circuits which correspond to exercising for approximately 30 minutes followed by a standardized stretching routine.
Arm Title
Arm II (no formal exercise intervention)
Arm Type
No Intervention
Arm Description
Patients do not participate in a formal exercise program for 16 weeks. Patients are then offered the Curves exercise intervention.
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Intervention Description
Undergo Curves exercise program
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in 60 minutes mean olive tail moments measured by the Comet assay
Description
Comet assay data will be analyzed according to methods by Wiklund et al. Log-transformed, mean Olive tail moments, assessing DNA damage, will be calculated and compared using a paired t-test. For the ex vivo analyses using a challenge assay, Log-transformed, mean Olive tail moments will be calculated before and after the introduction of the damaging agent at 0, 1 and 6 hours. Differences between the changes will be analyzed using the paired t-test. Multivariate analysis of variance (MANOVA) for repeated measure will be performed and linear regression models will be fitted.
Time Frame
Baseline to 16 weeks
Title
Change in level of interleukin-6 (IL-6) cytokine measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Description
Paired t-tests will be used to compare pre-exercise cytokine concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.
Time Frame
Baseline to 16 weeks
Title
Change in telomerase activity using the Trypan blue method and ImagedQuant
Description
Paired t-tests will be used to compare pre-exercise telomerase activity in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.
Time Frame
Baseline to up to 16 weeks
Secondary Outcome Measure Information:
Title
Change in the number of gamma-H2A histone, member X (H2AX) foci measured by the gamma-H2AX assay
Description
First, gamma-H2AX foci will be counted, and compared using the paired t-test. Second, for the ex vivo analyses gamma-H2AX foci will be counted before and after the introduction of a damaging agent at 0, 1 and 6 hours. For each time point, a foci change will be obtained. Differences in the foci changes at baseline and 16-weeks will be analyzed using the paired t-test. MANOVA for repeated measures will be performed to allow for the assessment of overall multivariate and univariate results, and linear regression models will be fitted.
Time Frame
Baseline to 16 weeks
Title
Change in C-reactive protein (CRP) and levels of cytokines measured by the 13 Plex-Immunology Multiplex Assay by EMD Millipore
Description
Paired t-tests will be used to compare pre-exercise CRP and cytokines concentrations in order to test whether the 16-week Curves exercise intervention decreased markers of inflammation. As secondary analysis linear regression models will be fitted.
Time Frame
Baseline to 16 weeks
Title
Adherence to the study protocol
Description
The CurvesSmart card will record both adherence of going to the sessions and completion of the circuit. Adherence will be analyzed as a continuous variable. During the 16-week testing session, women will be asked what barriers to adherence they may have experienced during the intervention.
Time Frame
16 weeks
Title
Changes in weight
Description
A repeated measures analysis of variance (ANOVA) will be used.
Time Frame
Baseline to 16 weeks
Title
Changes in BMI
Description
A repeated measures ANOVA will be used.
Time Frame
Baseline to 16 weeks
Title
Changes in percent body fat
Description
A repeated measures ANOVA will be used.
Time Frame
Baseline to 16 weeks
Title
Changes in cardiopulmonary function
Description
A repeated measures ANOVA will be used.
Time Frame
Baseline to 16 weeks
Title
Changes in muscle strength
Description
A repeated measures ANOVA will be used.
Time Frame
Baseline to 16 weeks
Title
Changes in functional capacity
Description
A repeated measures ANOVA will be used.
Time Frame
Baseline to 16 weeks
Title
Changes in quality of life scores
Description
Changes in quality of life scores will be measured by Cohen's 10-item perceived stress scale, the Fatigue Symptom Inventory, Rosenberg Self-esteem Scale, the Centers for Epidemiology Depression (CESD) Scale, the state trait anxiety index (STAI), the Functional Assessment of Cancer Therapy-Breast scale (FACT-B+4), and Short Form-36 (SF-36) questionnaires. A repeated measures ANOVA will be used.
Time Frame
Baseline to 16 weeks
Title
Incidence of exercise-attributed injury
Description
During the 16-week testing session, women will be asked details about any injuries or discomfort they may have experienced during the participation in the exercise intervention.
Time Frame
16 weeks
Title
Change in telomere length as measured by quantitative polymerase chain reaction
Description
Paired t-tests will be used to compare pre-exercise telomere length in order to test the 16-week Curves exercise intervention. As a second analysis regression models will be fitted. Potential confounding factors that may contribute to differences within the two groups of women (e.g. BMI, exercise intensity, etc.) will be investigated and included as appropriate. The impact of exercise intensity via CurvesSmart card will also be examined.
Time Frame
Baseline up to 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study will be conducted in women who have been diagnosed with a first primary invasive estrogen receptor (ER) positive (+) breast cancer (stages I-IIIa) who are within the first 3 years post-treatment The study will be conducted in postmenopausal women Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately Postmenopausal, defined as meeting any of the following criteria: Periods stopped more than 6 months ago Bilateral oophorectomy Not already classified as pre- or peri-menopausal Started using hormone therapy for menopausal symptoms before periods stopped, and/or Hysterectomy before age 56 years but aged 56 years or more at baseline Any body mass index (BMI) Sedentary (have not participated in a regular exercise program in the past 12 months) Nonsmokers (not smoking during previous 12 months) Willing and able to travel to the exercise facility Diagnosed with a first primary invasive ER+ breast cancer (stages I-IIIa) Have undergone a lumpectomy or mastectomy Have completed adjuvant chemotherapy and/or radiation within the past 3 years prior to study enrollment (when cytokine levels are predicted to be high) and able to initiate an exercise program May use adjuvant endocrine therapy if use will be continued for duration of study period All subjects must have the ability to understand and the willingness to sign a written informed consent Exclusion Criteria: History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity Regular, necessary use of nonsteroidal anti-inflammatory drugs (NSAIDs) (will be asked to stop use during study period) Currently taking postmenopausal hormone replacement therapy Stage IV or distant metastatic disease Planned reconstructive surgery with flap repair during study period Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Clague DeHart
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors

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